BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 17959357 · Received October 18, 2023

    Report

    Report Number
    2955842-2023-19340
    Event Type
    Injury
    Date Received
    October 18, 2023
    Date of Event
    September 20, 2023
    Report Date
    September 20, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL POWER MONITOR (UPM) WAS ANALYZED AND FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT REPLICATE THE CUSTOMER REPORTED COMPLAINT. IN-HOUSE FA INSTALLED AND TESTED THE UPM ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE BOARD WAS CONFIGURED AND PROGRAMMED WITHOUT ISSUE. THE SYSTEM STARTED UP WITHOUT ANY ERROR. THE UPM RAN 20 POWER CYCLES WITH THIS PART, AND ALL PASSED. ALL THE GANTRY MOTORS WERE MOVED THE FULL RANGE OF MOTION WITHOUT ANY ISSUE. THE BATTERY WAS CHECKED AND PASSED. THE UPM REMAINED ON THE TEST FOR 2 HOURS IN NORMAL OPERATION WHILE TESTING OTHER PARTS, AND IT PERFORMED WITHOUT ANY ERROR.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE UNIVERSAL POWER (UPM) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT REGARDING REPEATED ERRORS WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RECIPIENT TRANSPLANT SURGICAL PROCEDURE, THE SYSTEM HAD AN ERROR 861 REPORTED SINGLE TIME DURING TROUBLESHOOTING. THE REPORTED ISSUE WAS RESOLVED AFTER POWER CYCLE. THE PROCEDURE WAS CONVERTED TO OPEN WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE CUSTOMER DISABLED THE USM1 TO RESOLVE THE ISSUE AND THE SYSTEM WAS FUNCTIONAL WITH THREE ARMS. THE PROCEDURE WAS A ROBOTIC RECIPIENT TRANSPLANT. THE SIGNIFICANCE OF FUNCTIONING ALL 4 ARMS WAS VERY HIGH TO ENSURE EFFICIENT HANDLING, MANIPULATION OF THE TRANSPLANT KIDNEY AND FOR PROPER APPROXIMATION DURING MICRO SUTURING, THEREFORE THE CUSTOMER SWITCHED TO OPEN SURGERY. THERE WAS NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS (E.G. UNEXPECTED BLEEDING, ANASTOMOTIC LEAK, BLADDER/URETER DAMAGE, NERVE DAMAGE ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586528 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-47 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES